Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome

Phase 2

Not yet recruiting

• Conditions: ARDS; Covid19; SARS-CoV Infection; ARDS, Human
• Interventions: Drug: Instilled T3; Other: Placebo Therapy

• Registration Number: NCT04725110
• Lead Sponsor: University of Minnesota

Brief Summary

Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.

Detailed Description

Post-hospitalization follow-up for 6 and 12-months of survival and end-organ dysfunction (lung, heart, kidney, neuropsychological), plus quality of life and return to work of those previously working

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-26
• Last Update Posted: 2023-12-27
• Study Start: 2024-07-01
• Primary Completion: 2028-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,

• Diagnosis of ARDS by the Berlin Criteria (2012):

  1. Onset: < 7 days
  2. Chest x-ray: Bilateral Patchy Opacities, Infiltrates
  3. Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O
  4. Pulmonary Edema: Not fully explained by cardiogenic etiology
  5. Hypoxia: PaO2/FIO2 Ratio < 300, or O2Sat/FIO2 Ratio < 315

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T3 Intervention	Instilled T3	Participants in this arm will receive the experimental intervention.
Placebo Therapy	Placebo Therapy	Participants in this arm will receive placebo therapy.

Primary Outcome Measures

Name	Time	Method
Change Extravascular Lung Water Index	1 hour	EVLWI is calculated as ml of extravascular lung water fluid reported by VolumeView system (Edwards Lifesciences) divided by patient's body weight in kg. EVLWI will be measured at baseline and 1 hour post T3 installation to calculate change in EVLWI. Lower EVLWI values indicate greater treatment efficacy.

Secondary Outcome Measures

Name	Time	Method
New York Heart Association (NYHA) Functional Classification	30 days	Outcome is reported as the number of participants in each arm who fall into each of 4 categories: 1 (no limitation in normal physical activity), 2 (mild symptoms only in normal activity), 3 (marked symptoms during daily activities, asymptomatic only at rest), and 4 (severe limitations, symptoms even at rest).
Number of Ventilator-Free Days	30 days	Outcome is reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Creatinine Concentration	4 days	Outcome is reported as the number of participants in each arm with abnormally high plasma creatinine concentration (greater 1.21 milligrams per deciliter).
Glomerular Filtration Rate	4 days	Outcome is reported as the number of participants in each arm with impaired kidney function, defined as a glomerular filtration rate (GFR) less than 60 mL/min/1.73 m\^2.
Length of ICU Stay	Baseline to ICU discharge up to 30 days	Outcome is reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
30-day Survival	30 days	Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States